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Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia (CONA)

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ClinicalTrials.gov Identifier: NCT00541944
Recruitment Status : Unknown
Verified April 2008 by University of Wuerzburg.
Recruitment status was:  Recruiting
First Posted : October 10, 2007
Last Update Posted : April 28, 2008
Sponsor:
Information provided by:
University of Wuerzburg

Tracking Information
First Submitted Date October 9, 2007
First Posted Date October 10, 2007
Last Update Posted Date April 28, 2008
Study Start Date April 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: October 9, 2007)
Establishment of an clinical algorithm to differentiate the different causes of hyponatremia [ Time Frame: One year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia
Official Title Not Provided
Brief Summary The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algorithm handling a prospective clinical categorization of hyponatremia and approving together the start of an appropriate symptomatic therapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum, plasma and urine
Sampling Method Non-Probability Sample
Study Population Patients treated in an University Hospital in Germany
Condition Hyponatremia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Fenske W, Störk S, Koschker AC, Blechschmidt A, Lorenz D, Wortmann S, Allolio B. Value of fractional uric acid excretion in differential diagnosis of hyponatremic patients on diuretics. J Clin Endocrinol Metab. 2008 Aug;93(8):2991-7. doi: 10.1210/jc.2008-0330. Epub 2008 May 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 9, 2007)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • hypoosmolar hyponatremia with serum sodium concentration ≤129 mmol/l and serum osmolality ≤ 280 mosm/kg;
  • age > 18 years;
  • letter of agreement.

Exclusion Criteria:

  • gravidity and lactation;
  • restricted decision-making-ability
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00541944
Other Study ID Numbers Wue-CONA-33/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor University of Wuerzburg
Collaborators Not Provided
Investigators
Principal Investigator: Bruno Allolio, MD Universtiy of Wuerzburg
PRS Account University of Wuerzburg
Verification Date April 2008